Utilizing focused ultrasound, the Sonablate system is a minimally invasive robotic device that delivers precise and focused ablative energy.

CARE CAPABILITIES

Minimally Invasive

Radiation-Free

Real-Time Imaging

Sonafuse (US / mpMRI Image Fusion)

TCM (Tissue Change Monitoring)

Prostate Care Revolutionized

Sonablate is the first SonaSurgery probe to be commercialized. This unique image-guided device allows physicians to create a customized plan for each patient’s individual prostate needs. Ultrasound energy, or sound waves, is transmitted through the rectal wall and focused at desired locations within the prostate identified by MRI and confirmed by ultrasound. At the focal point of these sound waves, tissue temperature rapidly rises to almost 90 degrees Celsius (195 degrees Fahrenheit), destroying the targeted tissue while surrounding tissue remains unharmed. Sonablate features integrated imaging and ablation transducers that are controlled automatically allowing Sonablate to AIM, ABLATE, and ANALYZE the results of the ablation.

How Does TCM Work?A radio frequency (RF) signal is sent to a targeted ablation site prior to delivery of HIFU and then another signal is sent after delivery of HIFU to the same site. TCM quantifies tissue changes based on a comparison of RF ultrasound pulse-echo signals at each ablation site. Easy-to-read on-screen color overlays and focal point markers are one of many indicators to guide HIFU delivery.

Sonalink

Sonalink is a remote viewing telecommunication application that is comes standard on every Sonablate system and is accessible by any facility that is in compliance with the terms of their purchase agreement. Sonalink “links” the room and the device being used to deliver a case with remote support personnel. Two-way visual and auditory communication is provided between the physician and remote personnel, along with a Sonaplan screen mirroring app. Sonalink allows the complete procedure, ranging from device setup to active computer-controlled HIFU delivery, to be remotely monitored by experienced support personnel. These specialists have the ability to interact with the physician and OR staff in real-time to answer questions and provide ongoing training and guidance in the use of the device.

SONABLATE SAFETY FEATURES

Total Acoustic Power (TAP) Control

Total acoustic power, or TAP, is adjustable for each individual dose of HIFU, allowing power to be aligned with the varying specific characteristics over the entire volume of the gland.

Reflectivity Index Monitor (RIM)

RIM is used to assist the physician in monitoring energy deposition in the rectal wall. The RIM box measures the pixel brightness level of the image as seen in a defined rectangular region (RIM box) which is placed such that it encompasses the rectal wall in both the live and reference sagittal images

Software compares changes in the image in the RIM box between the treatment and reference images, displaying a numerical RIM value as the pixel brightness level within the yellow box changes. A rising RIM value suggests that the region within the box is accumulating potentially excess heat that could damage the rectal wall. Specified safety conditions cause the software to halt the treatment automatically.

Clinical Applications

Comprehensive Prostate Care Model

Regulatory Statement

Sonablate® has 510(K) clearance in the U.S. and is indicated for the transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

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